PET CTNCT03146117
PET-DECT for Staging and Imaged Based Radiotherapy Planning in Lung Cancer
An observational study of PET CT, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The overall goal of this project is to investigate the diagnostic performance of integrated F-18 fluorodeoxyglucose-positron emission tomography (FDG-PET) and Dual Energy CT (DECT) imaging in determining the thoracic nodal status of small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC), and its impact… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PET CT
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 15 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The investigators plan to recruit a total of 50 individuals (male, female; age range 18-90 years) referred to undergo a clinically indicated PET-CT examination. Patients will be identified from the Radiology department schedule. With the proposed 50 patient data set, the investigators are neither targeting nor avoiding the selective recruitment of women and minorities. Given the narrow inclusion criteria, the investigators plan to recruit patients irrespective of demographics. The patient will be approached by IRB-approved study personnel under the direction of one of the licensed physician investigators listed on the study, either prior to or on the day of the planned PET-CT examination (a single study visit, with the objective to perform the clinically indicated imaging), with a full explanation and request for consent as required by the IRB. MUSC policies regarding patient consent will be followed. The study design is not randomized.
Who may be able to join
- To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
- Subject must have a suspected SCLC or NSCLC.
- Subject must be 18-90 years of age.
- Subject must have been referred for a clinically indicated PET-CT.
- Subject must provide written informed consent prior to any study-related procedures being performed.
- Subject must be willing to comply with all clinical study procedures.
Who cannot join
- The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)
- Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- By testing (serum or urine βHCG) within 24 hours before contrast agent administration, or
- By surgical sterilization, or
- Post-menopausal, with minimum one (1) year history without menses.
- Subject has impaired renal function (eGFR<30 mL/min).
Show all 11Show fewer
- Subject has an acute psychiatric disorder or is cognitively impaired.
- Subject is using or is dependent on substances of abuse.
- Subject is unwilling to comply with the requirements of the protocol.
- Subject has an allergy against iodinated contrast agents and cannot be premedicated.
- Subject is in acute unstable condition.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29401
About this study
Official title: Application of Integrated PET and Dual Energy CT Imaging for Staging and Imaged Based Radiotherapy Treatment Planning in Lung Cancer
The overall goal of this project is to investigate the diagnostic performance of integrated F-18 fluorodeoxyglucose-positron emission tomography (FDG-PET) and Dual Energy CT (DECT) imaging in determining the thoracic nodal status of small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC), and its impact on target volume delineation for image guided radiation therapy (IGRT) planning.
- Conditions
- PET CT
- Keywords
- PET CT
What is being measured
The primary outcome is the main question the study is designed to answer.
PET-CT accuracy for lung tumor and thoracic adenopathy detection
Knowledge gained during this study may potentially allow for an improvement in PET-CT accuracy for lung tumor and thoracic adenopathy detection, and for a more accurate definition of the RT target, decreasing the radiation dose delivered to normal tissue.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Apr 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Why it stopped: Recruit completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PET CTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Responsible party
- Sponsor
- Investigators
- Carlo De Cecco, MD PHD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146117
- Sponsor's protocol ID
- Pro00060975
- Status last verified
- Jun 2018
- First submitted
- 5 May 2017
- Last updated
- 21 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Integrated PET and Dual Energy CT Imaging for Staging and Imaged Based Radiotherapy Treatment Planning in Lung Cancer
- ClinicalTrials.gov ID
- NCT03146117
- Acronym / sponsor ID
- Pro00060975
- Conditions
- PET CT
- Keywords
- PET CT
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruit completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Siemens Corporation, Corporate Technology
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this project is to investigate the diagnostic performance of integrated F-18 fluorodeoxyglucose-positron emission tomography (FDG-PET) and Dual Energy CT (DECT) imaging in determining the thoracic nodal status of small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC), and its impact on target volume delineation for image guided radiation therapy (IGRT) planning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators plan to recruit a total of 50 individuals (male, female; age range 18-90 years) referred to undergo a clinically indicated PET-CT examination. Patients will be identified from the Radiology department schedule. With the proposed 50 patient data set, the investigators are neither targeting nor avoiding the selective recruitment of women and minorities. Given the narrow inclusion criteria, the investigators plan to recruit patients irrespective of demographics. The patient will be approached by IRB-approved study personnel under the direction of one of the licensed physician investigators listed on the study, either prior to or on the day of the planned PET-CT examination (a single study visit, with the objective to perform the clinically indicated imaging), with a full explanation and request for consent as required by the IRB. MUSC policies regarding patient consent will be followed. The study design is not randomized.
Key inclusion criteria (6 listed)
- To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
- Subject must have a suspected SCLC or NSCLC.
- Subject must be 18-90 years of age.
- Subject must have been referred for a clinically indicated PET-CT.
- Subject must provide written informed consent prior to any study-related procedures being performed.
Key exclusion criteria (11 listed)
- The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)
- Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- Subject has impaired renal function (eGFR<30 mL/min).
- Subject has an acute psychiatric disorder or is cognitively impaired.
- Subject is using or is dependent on substances of abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PET-CT accuracy for lung tumor and thoracic adenopathy detection
Time frame: One year
Knowledge gained during this study may potentially allow for an improvement in PET-CT accuracy for lung tumor and thoracic adenopathy detection, and for a more accurate definition of the RT target, decreasing the radiation dose delivered to normal tissue.
Results and safety
The study was stopped early (reason given: Recruit completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlo De Cecco, MD PHD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PET CT, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruit completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET-CT accuracy for lung tumor and thoracic adenopathy detection (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.